CLASS II ONGOING Drug recall · Reported 19 Mar 2025 · FDA Enforcement Report
Latanoprost recalled by Aspen Biopharma Labs Pvt
Aspen Biopharma Labs is recalling Latanoprost, distributed in Florida. The recall was initiated on 7 Feb 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0264-2025
- FDA event ID
- 96209
- Recalling firm
- Aspen Biopharma Labs, Medchal Malkajgiri
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Feb 2025
- FDA classified
- 9 Mar 2025
- Reported
- 19 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Eye Drops
Timeline
| 7 Feb 2025 | Recall initiated by company | |
| 9 Mar 2025 | Classified by FDA | +30 days |
| 19 Mar 2025 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
Where it was distributed
Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot Numbers: HALAC0010123, exp. date Dec-2026 HALAC0050923, exp. date Aug-2027
Where was it sold?
Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 96209This product is part of a recall event; the main page for the event is Chlorambucil Container Description: The product recalled.